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临床试验/NCT07283432
NCT07283432已完成不适用

Effect of Education Given With Virtual Reality Glasses on Self-Care Ability of Patients After Bariatric Surgery

Ankara Yildirim Beyazıt University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Self-Care Abilities Scale

研究概览

简要总结

This research aims to determine the effect of training given via virtual reality glasses on the self-care ability of patients after bariatric surgery. This study is a single-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted with 60 patients who underwent colorectal surgery between August 2025 and December 2025. Participants will be randomized into two groups as the intervention group (n=30) and the control group (n=30). All patients in the experimental and control groups will be asked to fill out the "Informed Consent Form" and the "Self-Care Ability Scale" by the researchers on the day before the surgery, and the patients who agree to participate in the study will be given the "Patient Introduction Form" and "Self-Care Ability Scale" by the researchers. The "Simulator Illness Questionnaire" used in the Virtual Reality disease field will be applied to the patients in the experimental group, and their physiological conditions will be determined before the application. The patients in the experimental group will be given 15-20 minutes of discharge training with virtual reality glasses before being discharged after bariatric surgery. Watching videos with virtual reality glasses will be applied by the researcher in the patient rooms and beds. The Simulator Illness Questionnaire will be repeated at the end of the application. There will be no compelling effect that will negatively affect the health of the patients during the application, and the application will be terminated when the patients feel uncomfortable. A safe environment will be created so that there are no objects around the patients that they can bump into or trip over. The virtual reality glasses will be applied after a 5-10 minute trial period with the observer at the beginning. The patient can end the study at any time. If the patients use glasses/lenses, compliance will be checked. In addition, the patients in the experimental group will be counseled for 3 months.

The control group patients will not be subjected to intervention and the clinic's routine practices will continue.

All patients in the experimental and control groups will be asked about their Body Mass Index via telephone interviews at 1 and 3 months after bariatric surgery and the "Self-Care Ability Scale" will be filled out.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are 18 years of age or older, 65 years of age or younger,
  • Who have undergone laparoscopic sleeve gastrectomy or laparoscopic gastric bypass surgery,
  • Who have not developed any complications during or after the surgical procedure,
  • Who volunteer to participate in the study will be included in the study.

排除标准

  • Patients who have not undergone laparoscopic surgery,
  • Patients with neurological or psychological problems,
  • Patients who have been transferred to the intensive care unit after surgery, - Emergency and unplanned cases,
  • Patients diagnosed with cancer,
  • Patients with visual, auditory or systemic disorders,
  • Patients with balance problems,
  • Patients diagnosed with hypertension and hypotension,
  • Patients diagnosed with anxiety disorder or epilepsy will be excluded from the study.

结局指标

主要结局

Self-Care Abilities Scale

时间窗: preoperative day 1, postoperative 1. month and postoperative 3. month

The scale consists of 43 items. In our country, the scale was revised to 35 items. In the validity and reliability study of the scale, the Cronbach Alpha reliability coefficient was determined as 0.92. For the items containing statements about self-care abilities in the scale, there are the options "Does not describe me at all", "Does not describe me very much", "I have no idea", "Describes me a little" and "Describes me a lot". Each statement in the scale receives scores that can vary between zero and four. Reverse scoring is applied to the responses given to the eight items (3, 6, 9, 13, 19, 22, 26 and 31) containing negative expressions. The lowest score that can be obtained from the scale is zero, and the highest score is 140.

Simulator Sickness Questionnaire

时间窗: postoperative day 4

The Simulation Sickness Questionnaire (SSQ) is widely used to measure Virtual Reality illness. The simulator sickness questionnaire consists of 16 questions. These questions are located under 4 components: nausea (N), oculomotor (O), disorientation (D) and weighted total (T). The majority of studies conducted using the SSQ have reported only the Total Score score.

次要结局

未报告次要终点

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuba Yılmazer

Principal investigator

Ankara Yildirim Beyazıt University

研究点 (1)

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